There are certain challenges the clinical trial industry as a whole is still working to overcome, and one of these is sex and gender disparities in clinical research trial enrollment. There has been significant research into this effect over the years, with the industry accepting that the disparity between males and females in trial recruitment is real – and looking for ways to mitigate this effect.
At AGA Clinical Trials, we’re dedicated to promoting diversity within all our medical research studies, both in sex-gender areas and many others. Both for moral and practical reasons, we absolutely do not discriminate in trial enrollment – rather, we are commonly searching for the best possible balance in diversity to ensure the results of our trials are as accurate as possible across a wide swath of people. Here’s a primer on this area, including a definition of sex versus gender plus some data on how the clinical trial world is working toward greater equality.
Sex Vs. Gender
Firstly, particularly within the medical world where precision is vital, it’s important to differentiate between sex and gender. Sex refers to biological differences between male, female and intersex bodies at the time of birth; gender, on the other hand, refers to one’s identity as influenced by psycho-social, cultural and environmental factors.
Unbalanced Trial Enrollment
Sex-gender inclusion has long been an issue in medical trials, as we noted above, though this has begun to change in recent years. However, more work is still needed, as research continues to show that females are underrepresented in preclinical and early-phase clinical trials.
This is concerning not only for ethical reasons, but also because it simply makes trials less effective. There are several major differences in medicine based on sex, which we’ll discuss below.
Here are a few examples of significant medical research areas that may be underserved by imbalances in sex-gender patient enrollment:
- Gastrointestinal toxicity: This is a condition where multiple areas of research have indicated that female bodies are more likely to be susceptible.
- Cancer risk: Some research has shown potential for cancer risk associated with the use of sex hormones. In addition, there is a hypothesized but largely unstudied risk for reproductive cancers in transgender men and women who have undergone sex reassignment therapy.
- COVID-19: There have even been more recent concerns raised about exclusion of sex and gender considerations among COVD-19 studies, both in terms of treatment and prevention of this novel disease that’s spread the globe over the last year.
As we noted above, this is an area where the medical research world is making major efforts to push forward. For more information on how we’re contributing to efforts in diversity in patient recruitment and enrollment, speak to the staff at AGA Clinical Trials.